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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 15MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 15MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FD40015
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Thromboembolism (2654); Ischemia Stroke (4418)
Event Date 12/31/2020
Event Type  Injury  
Manufacturer Narrative
Device is implanted in patient.
 
Event Description
It was reported that more than 24 hours post procedure with the subject flow diverter, the patient suffered a minor stroke with left arm weakness. Imaging done confirmed a minor stroke of the right frontale territory and regular patency of the stent, and of the right arterial circulation. Physician's opinion was that there was probably a thromboembolism related to the presence of the subject flow diverter. No medical intervention or medication was given due to this event. Event was classified as a post-procedural complication because the patient remained asymptomatic for more than 24 hours post procedure. The following day, the patient recovered from all the deficits and is currently asymptomatic but had prolonged hospitalization. Event was related to subject device and procedure.
 
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Brand NameSURPASS EVOLVE 4.0MM X 15MM - CE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key11230892
MDR Text Key228698775
Report Number3008881809-2021-00050
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P170024/S003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberFD40015
Device Lot Number21805681R
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/26/2021 Patient Sequence Number: 1
Treatment
EXCELSIOR XT-27 MICRO CATHETER (STRYKER); TARGET COILS (STRYKER)
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